Impact of Parathyroidectomy on Renal Function

Primary Hyperparathyroidism Clinical Trial

— PARA-REIN  

Official title:

Impact of Parathyroidectomy on Renal Function in Patients With Primary Hyperparathyroidism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04798092
• Other study ID #: 2020PI099
• Status: Recruiting
• Start date: January 1, 2010
• Est. completion date: January 2023

Study information

• Verified date: January 2022
• Source: Central Hospital, Nancy, France
• Contact: laurent Brunaud
• Email: l.brunaud[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Primary hyperparathyroidism (PHPT) is a disorder of one or more of the parathyroid glands. The parathyroid gland(s) becomes overactive and secretes excess amounts of parathyroid hormone (PTH). As a result, the blood calcium rises to a level that is higher than normal. PHPT is associated with several other metabolic complications as osteoporosis, kidney stones, hypertension, insulin resistance, cardiac calcifications, cardiac arrhythmias, and kidney failure. Renal function deterioration over time has also been reported. However, the role of parathyroidectomy on renal function remains controversial in patients with PHPT. In some studies, surgical cure of PHPT has been shown to halt renal function deterioration in patients with coexisting renal disease. On the other hand, other studies showed no significant impact of parathyroidectomy on renal function. Consequently, the goal of this study was to evaluate renal function before and after parathyroidectomy in a large cohort of patients with pHPT.

Description:

Primary hyperparathyroidism (PHPT) is a disorder of one or more of the parathyroid glands. The parathyroid gland(s) becomes overactive and secretes excess amounts of parathyroid hormone (PTH). As a result, the blood calcium rises to a level that is higher than normal. PHPT is associated with several other metabolic complications as osteoporosis, kidney stones, hypertension, insulin resistance, cardiac calcifications, cardiac arrhythmias, and kidney failure. Renal function deterioration over time has also been reported. However, the role of parathyroidectomy on renal function remains controversial in patients with PHPT. In some studies, surgical cure of PHPT has been shown to halt renal function deterioration in patients with coexisting renal disease. On the other hand, other studies showed no significant impact of parathyroidectomy on renal function. Consequently, the goal of this study was to evaluate renal function before and after parathyroidectomy in a large cohort of patients with pHPT. Criteria are detailled in "Outcomes measures"

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients undergoing parathyroidectomy for primary hyperparathyroidism with surgical cure defined as postoperative normocalciemia

Exclusion Criteria:

• patients on dialysis
• GFR < 15 ml/min
• renal graft

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Primary Hyperparathyroidism

Intervention

Procedure:
• parathyroidectomy
surgical removal of parathyroid adenoma(s) with postoperative biological cure

Locations

Country	Name	City	State
France	CHRU Nancy	Vandœuvre-lès-Nancy	Lorraine

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in renal function	glomerular filtration rate (CKD in mL/min)	preoperative, postoperative at 3, 6, and 12 months
Secondary	Change in calcium	Blood calcium level (in mg/L)	preoperative, postoperative at 3, 6, and 12 months
Secondary	Change in parathormone	Blood parathormone level (in ng/dL)	preoperative, postoperative at 3, 6, and 12 months
Secondary	Change in vitamin D	Blood vitamine D level (in ng/mL)	preoperative, postoperative at 3, 6, and 12 months
Secondary	Change in urinary calcium	Urine calcium level (in mg/24h)	preoperative, postoperative at 3, 6, and 12 months
Secondary	Change in insulin	Fasting blood insuline level (in mUI/L)	preoperative, postoperative at 3, 6, and 12 months
Secondary	Change in glycemia	Fasting blood glucose level (in g/L)	preoperative, postoperative at 3, 6, and 12 months
Secondary	Change in osteocalcin	Blood osteocalcin level (in ng/mL)	preoperative, postoperative at 3, 6, and 12 months
Secondary	Change in bone alkaline phosphatases	Blood bone alkaline phosphatases level (in microgr/L)	preoperative, postoperative at 3, 6, and 12 months
Secondary	Change in aldosterone	Blood aldosterone level (in pg/mL)	preoperative, postoperative at 3, 6, and 12 months
Secondary	Change in renin	Blood active renin (in pg/mL)	preoperative, postoperative at 3, 6, and 12 months
Secondary	Change in total cholesterol	Blood total cholesterol (in gr/L)	preoperative, postoperative at 3, 6, and 12 months
Secondary	Change in HDL cholesterol	Blood HDL Cholesterol (in gr/L)	preoperative, postoperative at 3, 6, and 12 months
Secondary	Change in LDL cholesterol	Blood LDL Cholesterol (in gr/L)	preoperative, postoperative at 3, 6, and 12 months
Secondary	Change in triglycerides	Blood triglycerides (in gr/L)	preoperative, postoperative at 3, 6, and 12 months
Secondary	CAC scoring on CT scan	CAC score (actual value)	preoperative